The science behind making clinical trials 82x cheaper and saving millions of lives
Average cost: $2.6 BILLION per drug. 90% of that is wasted on bureaucracy, not science.
Takes 10-15 years to bring a drug to market. People die waiting.
Only 3-5% of patients can participate. Strict eligibility criteria exclude most people.
Conducted in specialized centers with ideal conditions. Results don't reflect real-world use.
Specialized research centers only
Strict eligibility criteria (excludes 95%+ of patients)
Frequent in-person visits required
Manual data collection and entry
Extensive monitoring and documentation
Artificial conditions (not real-world)
Cost: $2.6 BILLION per drug
Timeline: 10-15 years
Conducted in regular clinics and hospitals
Broad eligibility (includes real-world patients)
Minimal additional visits (part of routine care)
Automated data from electronic health records
Streamlined monitoring (focus on safety)
Real-world conditions (actual practice)
Cost: $32 MILLION per drug (82x cheaper)
Timeline: 2-3 years
Instead of creating artificial research environments, pragmatic trials happen during normal doctor visits. Patients receive care as usual, with minimal disruption.
Electronic health records (EHRs) automatically capture data. No need for expensive manual data entry or separate research databases. This alone saves billions.
No strict exclusion criteria. If you have the condition, you can participate. This makes trials faster to recruit, more representative, and more ethical.
Instead of measuring biomarkers in a lab, pragmatic trials measure what patients care about: survival, quality of life, symptom relief, hospital admissions.
Still FDA-approved and safe, but with less bureaucratic overhead. Focus on safety monitoring, not paperwork. Regulators are already embracing this approach.
Take it one step further: bring trials directly to patients, wherever they are.
Patients participate from home using telemedicine, wearables, and mobile apps.
Rural patients, working parents, and people with mobility issues can now participate.
No need for expensive research sites. Reduces costs by another 50-70%.
The COVID-19 vaccine trials used pragmatic and decentralized approaches to enroll 40,000+ participants in months instead of years. They proved these methods work at scale while maintaining safety and scientific rigor.
YES. PRAGMATIC TRIALS ARE JUST AS SAFE AS TRADITIONAL TRIALS.
Pragmatic trials still require FDA approval and oversight. Safety standards don't change.
EHR systems enable real-time safety monitoring across thousands of patients simultaneously.
Because pragmatic trials include diverse, real-world patients, they actually detect safety issues that artificial trials might miss.
The NIH, FDA, and leading medical institutions already support and conduct pragmatic trials.
844 new drugs tested per year (vs current 10)
18 million lives saved annually
$163B annual benefit from peace + health dividends
564:1 ROI - Best investment in human history
Countries sign the 1% Treaty
1% of military budgets redirected to DIH
DIH funds pragmatic trials globally
New treatments discovered 82x faster
A pragmatic trial in the 1980s discovered that aspirin reduces heart attack deaths by 23%. Cost: $50,000. Lives saved: millions.
Traditional trial would have cost $50+ million and taken years longer.
Pragmatic trial identified dexamethasone as a COVID treatment in just 3 months. Enrolled 11,000+ patients across 176 hospitals.
Saved an estimated 1 million lives in the first year alone.
Pragmatic trial tested asthma medication in real-world GP practices. Enrolled 4,000+ patients in routine care settings.
Cost 70% less than traditional trial, results more applicable to actual patients.
NIH-funded pragmatic trial testing aspirin for heart disease prevention. Using EHR data from 15,000+ patients across 40 sites.
Demonstrates that pragmatic trials work at scale in the U.S. healthcare system.
See what the platonic ideal of healthcare and clinical trials will look like after the adoption of the 1% Treaty.
Search for trials based on your condition, location, and preferences.
Review comprehensive outcome data before deciding to join a trial.
Complete informed consent and enroll in your chosen trial.
Schedule lab tests, provider visits, and import your health records.
Record your diet, treatment adherence, symptoms, and more.
View personalized analytics about your health and treatment response.
Receive personalized daily check-ins from your FDAi AI agent that monitors your progress, collects data, and provides insights in a conversational way.
Your personal health assistant
Good morning, Sarah! How are you feeling today after your treatment yesterday?
I'm feeling better today. The headache is gone but I still feel a bit tired.
That's good progress! Your fatigue has decreased by 40% since last week. Would you like to see how your symptoms compare to others in your trial?
Yes, please show me.
Our AI analyzes patient EHR data to identify and rank the most suitable and effective clinical trials, saving you time.
Review detailed outcome labels, compare trial arms (including placebo/standard of care), and assign patients directly.
Track key metrics, patient-reported outcomes, and overall trial status through an intuitive dashboard.
P12345: Mild ARIA reported
P67890: Headache (resolved)
The new and improved FDA.gov would make it effortless for researchers to create a trial and invite patients to join.
Upload protocols, pre/post-clinical data, and register your supply chain through the FDA.gov V2's intuitive interface.
Automatically receive and select liability insurance quotes per subject with transparent pricing.
Define patient pricing, required data collection, and refundable deposits to optimize your trial.
Track inventory, fulfill patient orders, and manage the entire treatment supply chain with end-to-end visibility.
Access real-time insights, analyze effectiveness data, and make informed decisions with comprehensive dashboards and reporting tools.